Systems having a centralized database for use in the collection, management and dissemination of information relating to medical procedures

ABSTRACT

A system for the collection, management, and dissemination of information relating at least to a medical procedure is disclosed. The system includes a user interface adapted to provide raw data information at least about one of a patient, the medical procedure, and a result of the medical procedure. A medical device communicates with the user interface, receives the raw data information from the user interface, and generates operational information during use. A central database communicates at least with the medical device and receives data from the medical device. The central database is used to create related entries based on the raw data information and the operational information and optionally transmits the related entry to the medical device or the medical device user. The related entry includes information that provides guidance based on previously tabulated, related medical procedures. A system for the iterative analysis of medical standards is also disclosed along with methods for the evaluation of medical procedures and standards.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.10/143,562, filed on May 10, 2002, the contents of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

A person's natural tendency is to perform a known task in the samemanner in which he has performed the task numerous times in the past.

Similarly, when performing a particular task, a person's naturaltendency is to rely on the same equipment that he has used successfullyin the past.

Additionally, where standards have been established for the completionof a particular task, a person's natural tendency is to follow theaccepted standards.

In the medical profession, these three tendencies are particularlypronounced. Naturally, where a person's health and life are at stake, itis entirely justified for those in the medical profession to take aconservative approach to medical treatment by relying on trustedtechniques, equipment, and standards.

While conservatism fosters the perpetuation of sound and trusted medicalprocedures, the continued use of reliable equipment, and the practice ofaccepted standards, it also fosters a certain degree of stagnation.Those in the medical profession are less likely to embrace new anduntested medical techniques, equipment, and standards before they havebeen proven to be safe and effective. In fact, those in the medicalprofession are likely to follow accepted medical practices, use acceptedequipment, and rely on accepted standards even though technology mayhave advanced sufficiently to render them obsolete or, at a minimum,cast doubt on their current efficacy or applicability.

All of this means that new medical techniques, technologies, andstandards, even those that may be more cost effective and beneficialthan tried and tested techniques, technologies, and standards, are slowto be adopted. This slows the progress of medicine.

Presently, in order to assess the efficacy of a change in a medicaltechnique, technology, or standard, a physician must perform theprocedure, use the technology, or test the new standard with a number ofpatients in a number of multi-site clinical trials. Naturally, thosetrials must include a control group for proper assessment of the medicaltechnique, technology, or standard.

Following clinical trials, the physician typically describes andpublishes his findings in a suitable medical journal. In addition, hemay present his findings to his peers at medical conferences. As can bereadily understood, this process often may take a number of years.Moreover, the sheer magnitude of the undertaking often means that onlythe most deserving of medical techniques and technologies and theestablishment of the most beneficial standards are pursued.

In addition, the enormous costs associated with studies prohibit mostdoctors and physicians from testing any techniques or equipment or fromestablishing new standards without assistance from large companies andresearch organizations that have sufficient financial resources to fundthese activities.

For example, when performing a diagnostic evaluation that involves theuse of a medical injector in combination with a scanning device (such asa CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) scanner),it may be the widely accepted practice to inject contrast media into thepatient at a rate of X ml per minute to assure that the diagnosticevaluation provides useable information to the physician. The standardrate of injection probably was established through the clinical trialmethod described above.

It may be the case, however, that the rate of injection of contrastmedia may not need to be as high as the rate recommended due to advancesin scanning technology. For example, the sensitivity of the scanner usedfor a particular diagnostic may have improved (and probably hasimproved) since the development of the standard(s) associated with itsuse. Some doctors will adapt their protocols to the capabilities of thenew equipment. These are often called “rapid adopters.” However, otherpractitioners, despite advances in technology, may continue to use theestablished contrast flow rate simply because the flow rate falls withinthe standard established for the particular diagnostic technique.

The result of applying the established standard irrespective of anyadvances in medical equipment has several consequences. First, if thescanner's sensitivity has increased so that the standard flow rate is nolonger required, the patient receives more contrast media than isrequired for the medical diagnostic. Not only does this increase thecost of the procedure (because more contrast media is used than isrequired), it also increases the possibility that the patient may havean adverse reaction to the contrast media. In addition, and perhaps moreimportantly, due to its increased sensitivity, the scanner's performancemay be hindered by the use of contrast media at the standard rate if itperforms optimally at a lower injection rate that is not recognized bythe standard.

The same reluctance may be exhibited when new equipment is brought tothe medical arena. For example, if an improved scanner is offered foruse, rapid adopters will purchase and use the equipment to the benefitof their patients. Other doctors or practitioners may resist purchasingand using the equipment until its safety and efficacy are proven. As aresult, patients may not benefit from the advances that the equipmentoffers to provide a more accurate diagnosis. Because of the cost anddifficulty in proving the benefits of the improvement, as mentionedabove, there often is significant delay in making this improvementavailable to all patients.

In summary, what the prior art and current practice fails to provide isa system or methodology for the appropriately rapid adoption ofstep-wise, incremental advances in medicine that develop on a continuingbasis, the kind of incremental changes that result from daily practice.Simply, there are few, if any, existing mechanisms by which incrementaladvances may be shared with other practitioners in the medicalprofession to more rapidly advance medical care and quality, among otherthings.

The divergence between the conservative approach to the advance ofmedicine and the need for the reevaluation of standards and theevaluation of new medical techniques and equipment has created atechnology gap in modern medicine that cries out for a solution.

At the same time, technological advances relating to informationcommunication have been exploding. Home utility meters can automaticallytransmit readings for billing purposes. Copiers and other equipment cancall a central office when their self-test software detects a failure orimminent failure. And, for some equipment, it is possible to remotelyconduct equipment diagnosis and change equipment settings or software.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a systemthat collects and disseminates information to facilitate the derivationand establishment of medical standards and best medical practices.

It is still another object of the present invention to provide a systemand method that closes the gap that exists in modern medicine betweenmethods and technologies that are being used and improvements to thosemethods and technologies that are being developed and introduced.

To accomplish this, the system of the present invention provides acentralized management of information about the medical equipment,procedures performed with that equipment, and the results of thoseprocedures. The centralized database establishes a repository ofinformation that can be relied upon to facilitate step-wise advancementsin medical techniques, technologies, and standards.

In one aspect, the present invention also concerns a method foraccumulating information about medical equipment and procedures with aparticular sensitivity to reducing the cost associated with themanufacture and use of such equipment.

In another aspect, the present invention permits the centralizedaccumulation of information so that medical standards may bere-evaluated and adjusted continually.

In accordance with these objectives, the present invention offers amethod and apparatus that fosters the collection and dissemination ofinformation about newly-developed medical techniques, technologies,equipment, and standards so that new and improved techniques,technologies, equipment, and standards can be more rapidly brought topatients who may benefit from them, when appropriate.

One aspect of the invention is to provide an automated “benchmarking”procedure for the collection of information about the efficacy ofmedical devices, techniques, and standards that proliferate in themedical arena.

Among other things, “benchmarking” is now recognized as a powerful toolfor improving the quality of products or services while reducing thecosts associated with the use and manufacture of those products and thedevelopment of those services. As the word is now understood,“benchmarking” is a procedure, the basis of which involves thecollection and assessment of sufficient volumes of information so thattrends and outliers in that information may be identified and analyzed.Benchmarking may be used to learn how others accomplish similar tasks,what defects appear in products on a per million basis (or less), howsatisfied doctors and physicians are with particular products, trends inemployee turnover, and the efficacy of daily practices, depending uponthe topic or field to which it is applied.

Successful benchmarking requires the successful collection andorganization of the information that forms the basis of the analysis. Assuch, a benchmarking procedure that relies on individuals to manuallycollect information is less likely to succeed than a benchmarkingprocedure where the information is gathered and collected in anautomated fashion. In other words, if data collection is automated orcan be made part of routine operations, the collection of usefulinformation is greatly enhanced.

Therefore, one object of the present invention capitalizes on theconcept of benchmarking in the medical profession by collectinginformation before, during, and after a medical procedure so that theinformation may be analyzed and used to support changes in medicaltechniques and devices that are being developed or are soon to bedeveloped.

The data collection aspect of the present invention also assists in theevaluation and modernization of standards and best medical practicesused daily by medical practitioners.

In view of the foregoing, the present invention provides a system forthe collection, management, and dissemination of information relating atleast to a medical procedure. The system includes a user interfaceadapted to provide raw data information at least about one of a patient,the medical procedure, and a result of the medical procedure. At leastone medical device in communication with at least the user interface isprovided. The at least one medical device is adapted to receive the rawdata information from the user interface, to generate operationalinformation before, during, and after use, and optionally to transmitthe raw data information and the operational information back to theuser interface. A central database in communication at least with the atleast one medical device is also provided. The central database isadapted to receive and tabulate the raw data information and theoperational information, to select at least one related entry based onthe raw data information and the operational information, and optionallyto transmit the related entry to at least the at least one medicaldevice. The at least one related entry includes information thatprovides at least guidance based on previously tabulated, relatedmedical procedures. In addition, the return of information to the usermay be through a totally separate path, for example a paper report or aninternet web page.

The present invention also provides a system for the collection,management, and dissemination of information relating at least toadoption and use of a medical standard. The system includes a userinterface adapted to provide raw data information at least about one ofa patient, a medical procedure, a result of the medical procedure, andthe medical standard employed during the medical procedure. At least onemedical device in communication with at least the user interface is alsoprovided. The at least one medical device is adapted to receive the rawdata information from the user interface, to generate operationalinformation before, during, and after use, and optionally to transmitthe raw data information and the operational information. The systemincludes a central database in communication at least with the at leastone medical device. The central database is adapted to receive andtabulate the raw data information and the operational information, toselect at least one related entry based on the raw data information andthe operational information, and optionally to transmit the relatedentry to at least the at least one medical device. The at least onerelated entry includes information that provides at least guidance basedon previously tabulated information and the medical standards employed.

It is another object of the present invention to provide a method forstep-wise, iterative evaluation of information relating at least to amedical procedure. The method includes providing raw data to a userinterface at least about one of a patient, the medical procedure, and aresult of the medical procedure, providing the raw data from the userinterface to a medical device, wherein the user interface is incommunication at least with the medical device, generating operationalinformation by the medical device before, during, and after use,transmitting the raw data and the operational information from themedical device to a central database, which is in communication at leastwith the medical device, receiving and tabulating the raw datainformation and the operational information by the central database,selecting at least one related entry by the central database based onthe raw data information and the operational information, and optionallytransmitting the related entry to at least the medical device. The atleast one related entry includes information that provides at leastguidance based on previously tabulated, related medical procedures.

The present invention also provides a method for step-wise, iterativeevaluation of information relating at least to employment of a medicalstandard. The method includes providing raw data to a user interface atleast about one of a patient, the medical procedure, a result of themedical procedure, and the medical standard employed, providing the rawdata from the user interface to a medical device, wherein the userinterface is in communication at least with the medical device,generating operational information by the medical device before, during,and after use, transmitting the raw data and the operational informationfrom the medical device to a central database, which is in two-waycommunication at least with the medical device, receiving and tabulatingthe raw data information and the operational information by the centraldatabase, selecting at least one related entry by the central databasebased on the raw data information and the operational information, andoptionally transmitting the related entry to at least the medicaldevice. The at least one related entry includes information thatprovides at least guidance based on previously tabulated, employedmedical standards.

Other objects of the present invention will be made apparent from thedrawings and description that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present invention are described in the paragraphsthat follow and are illustrated by the figures below, in which:

FIG. 1 is a block diagram of a first embodiment of the presentinvention;

FIG. 2 is a block diagram of a second embodiment of the presentinvention;

FIG. 3 is a block diagram of a third embodiment of the presentinvention, which is a first variation of the first embodimentillustrated in FIG. 1;

FIG. 4 is a block diagram of a fourth embodiment of the presentinvention, which is a second variation of the first embodimentillustrated in FIG. 1;

FIG. 5 is a block diagram of a fifth embodiment of the presentinvention, which is a first variation of the second embodimentillustrated in FIG. 2;

FIG. 6 is a block diagram of a sixth embodiment of the presentinvention, which is a second variation of the second embodimentillustrated in FIG. 2;

FIG. 7 is a block diagram of a seventh embodiment of the presentinvention, which is a third variation of the second embodimentillustrated in FIG. 2;

FIG. 8 is a block diagram of a eighth embodiment of the presentinvention, which is a third variation of the first embodimentillustrated in FIG. 1;

FIG. 9 is a block diagram of the interaction of several embodiments ofthe present invention with one another;

FIG. 10 is a block diagram illustrating the variety of userscontemplated for the present invention; and

FIGS. 11A-11E provide selected details of one example application of thepresent invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the present invention will be described in relation to a systemand method for the development of a particular group of medicaltechniques, devices, and standards, it should be understood that thepresent invention is not limited to a system or method concerning onlymedical techniques, devices, and standards. As will be understood bythose skilled in the art, the system and method of the present inventionhave wide applicability to the development of new and effectivetechniques, devices, and standards that may be used in medicine or anyother field that may benefit from this iterative analytical tool. Forexample, it has been suggested that the system and method of the presentinvention may be utilized by wineries to improve the quality of winesthrough the sharing of production-related information.

Because of its far-reaching applicability, to facilitate anunderstanding of the present invention, the discussion that followsfocuses primarily on the application of the present invention todevelopments related to injectors used for the injection of contrastmedia during certain medical diagnostic procedures.

FIG. 1 illustrates one embodiment of a system 10 of the presentinvention. System 10 includes a user interface 12 in communication withat least one medical device 14. Medical device 14, in turn, is incommunication with a central database 16.

As illustrated, user U may provide input to user interface 12 through acommunication link 100. When two-way communication between user U anduser interface 12 is desired, user interface 12 may communicate withuser U via communication link 102.

Throughout this description, communication links from one component toanother will be discussed and illustrated. For clarity, the arrowsindicate the direction of the communication. The arrows may beunderstood to indicate either separate, one-way communication links.Alternatively, they may indicate a single communication link thatfacilitates two-way communication. As would be appreciated by thoseskilled in the art, the communication link(s) may be a telephone line, awireless communication link, or the Internet, among others.

User interface 12 may be a computer or other suitable electronic devicethat is capable of receiving information from an input device such as acomputer keyboard. It could also be a voice recognition system. Inaddition, it is preferred that user interface 12 includes means fordisplaying or otherwise communicating information to the user. Asuitable display includes a computer monitor or enunciator, among otherthings. Information inputted into user interface 12 is transmitted, bysuitable means, indicated as communication link 104, to medical device14, which is connected to and communicates with user interface 12 viacommunication link 106.

As would be understood by those skilled in the art, user interface 12need not be a stand-alone computer in order to practice the presentinvention. Instead, user interface 12 may be incorporated into medicaldevice 14 so that user interface 12 and medical device 14 are anintegrated unit. When combined in this manner, user interface 12 may bean input keyboard, mouse, stylus, touch-screen, or some other suitabledata input device that is manufactured as a part of medical device 14.

In the preferred embodiment of the present invention, user interface 12is a stand-alone computer through which data may be inputted intomedical device 14. User interface 12 also is preferably arranged so thatinformation generated by medical device 14 may be communicated (viacommunication link 106) to user interface 12 and displayed to the userU, such as by a computer monitor, so that the practitioner or physician(the user) may monitor selected aspects of medical device 14 during itsoperation. Other information (for instance patient data from a HospitalInformation System, or procedure data from other medical devices)related to the medical procedure may also be displayed to the userthrough user interface 12.

While medical device 14 is designed to receive raw data inputted throughuser interface 12, it is also preferably designed to generateoperational information before, during, and after use. Operationalinformation may include any number of different data types. For example,medical device 14 may operate like a flight recorder where it generatesand stores real time information about its operation. Alternatively,medical device 14 may operate like a slow motion camera by generatingand storing operational data on a periodic basis. Alternatively it mayrecord the parameters of operation that were chosen by the user.

Regardless of the manner in which medical device 14 generates and storesoperational information, the operational information and the raw datainformation are both provided from medical device 14 to central database16 via communication link 108 where the information is collated,tabulated, and stored.

In the preferred example, central database 16 is a central computer thatis capable of receiving, tabulating, and storing large quantities ofinformation. Central database 16 is connected with medical device 14 sothat they are in communication with one another via communication links108, 110. This communication may be a hard-wired connection or it may bea wireless communication, as would be understood by those skilled in theart. For example, medical device 14 may communicate with centralcomputer 16 through conventional telephone lines or through cellular ordigital wireless channels. Alternatively, medical device 14 maycommunicate with central database 16 through the Internet.

While it is desirable that the user have the best practice orbenchmarking data available immediately, in many situations, theinformation collected about procedures and outcomes does not need to becollected into the data base in real time, since it takes many casesover some time before a recommendation would be changed. In thissituation, the information or data described herein could rely onphysical transportation such as the postal system, other paper deliverysystem, or the mechanisms described in U.S. Pat. No. 5,739,508, which isincorporated herein by reference.

In addition, central database may be constructed so that it may be incommunication with user U through one or both of communication links112, 114. In this arrangement, central database 16 may communicate withuser U indirectly through medical device 14 and user interface 12 ordirectly with user U, depending on the information type being exchanged.

It is preferred that user interface 12, medical device 14, and centralcomputer 16 operate together to provide a seamless operation.Accordingly, it is contemplated that the three devices will operateusing a single data transmission format so that the data inputted intouser interface 12 or generated by medical device 14 is received easilyby central database 16 and vice versa.

To that end, user interface 12 preferably communicates with medicaldevice 14 through a connection 104, 106 whose operation is governed by adata transmission format such as the standard developed by the IEEE(Institute of Electrical and Electronics Engineers, Inc), which is knownas IEEE 1073. IEEE 1073 is a standardized communication format developedspecifically for use with medical devices so that those medical devicescommunicate with one another without the need for modifying theinterface formats between them.

For example, in a hospital environment, a patient may be connectedsimultaneously to a number of electronic devices such as a heart monitorand a respirator. Each of these devices is controlled individually by anoperating system that provides output data in a format typicallyrecognized only by the individual device. As a result, the two separatedevices traditionally operate independently of one another, because thedata that they generate are in formats that are not compatible with oneanother.

If, however, the two devices are constructed so that the data that theygenerate is in the same format, the two devices could communicate withone another easily. Understandably, if the two devices could communicatewith one another, the information generated by the heart monitor and therespirator potentially could be used by either device (or both devicessimultaneously) to detect aberrant patient conditions that neither oneof the devices could detect by itself. Without a standardized dataformat, such as IEEE 1073, the data from one piece of equipment mustpass through a filter or “translator” so that any other equipmentconnected to it might understand the data that it generates.

The work on IEEE 1073 has been driven by the need to efficiently,effectively, and in a timely manner collect a comprehensive set of datarelated to a specific patient, to, for example, avoid adverse drugevents or better manage the health care provided to that specificpatient. Other Hospital Information Systems aim to efficiently,effectively, and in a timely manner collect information related topatient care, primarily for billing and reimbursement. This inventioncarries that work to the next level by enabling collection and analysisof data across many patients, procedures and hospitals so that futurepatients can benefit.

With this in mind, one aspect of the present invention contemplates thatuser interface 12, medical device 14, and central computer 16 willcommunicate with one another using a common electronic language or dataformat such as IEEE 1073. As would be understood by those skilled in theart, however, neither a common electronic language nor standardizedcommunication format are required to practice the present invention. Tothe contrary, it is contemplated that other communication formats may beused, such as through a standard RS-232 port, so long as the devicescommunicate effectively with one another, especially in situations wherethis capability is retrofitted to previously developed devices or usewith devices from different manufacturers. As would be appreciated bythose skilled in the art, medical device 14 may communicate with userinterface 12 through one data transmission format and communicate withthe central database 16 via a second data transmission format, such asthe IEEE 1073.

Each of the basic elements of system 10 (as well as the other systemembodiments contemplated by the present invention) illustrated in FIG. 1is meant to represent any of a number of different components. In otherwords, each element is meant to correspond to one or more devices. Inaddition, as noted above, the various components that may be used withthe present invention are not limited to medical devices, even thoughthe preferred embodiment is directed to medical use.

In one aspect of the present invention, medical device 14 may combinethe operation of a contrast medium injector and a scanner such as a MRIscanner. User interface 12 may be a computer connected to medical device14 to provide input to medical device 14 and to optionally receiveoutput from medical device 14. Medical device 14 (whether one or moredevices in communication with one another), in turn, communicates with acentral database 16 to which medical device 14 sends information aboutthe procedure being performed. In return, medical device 14 may receivepertinent information from central database 16 and relay thatinformation to user interface 12 and/or user U. Alternately, medicaldevice 14 may receive information from database 16 for its operation.

The present invention contemplates that user interface 12 and/or user Uwill receive potentially a large amount of information encompassing abroad spectrum of possibilities. The following discussion providesexamples of at least some of the information that might be processed bythe present invention, highlighting information that might be relevantto a diagnostic in which a contrast media injector and an imager (suchas a MRI) are used in combination as medical device 14.

When conducting a particular medical procedure, the doctor orpractitioner may input patient-specific information into user interface12 and/or central database 16. Patient-specific information may include,for example, the weight, circulation time, age, disease (including a DRG(diagnostic related group) number that is the number used to catalogdiseases much like the Dewey decimal system is used to catalog books ina library), region of study, procedure type, time since admission, imagemodality, contrast media type, contrast media temperature, andmedication information for the particular patient. Additional examplesof information that may be useful to input can be found in U.S. Pat. No.5,840,026, which is incorporated herein by reference. The informationcould also include the algorithm or process that was applied to thepatient-specific data to determine other parameters of the procedure.

Information about the equipment used may also be inputted into the userinterface 12 and/or transmitted to central database 16. Such informationmay include, for example, syringe size, syringe volume, flow rate,phases, delays, the type of catheter used, and the number and type ofdisposables used. Equipment information may also encompass the name ortype of contrast media used, the manufacturing lot for the contrastmedia, or the volume, density, or viscosity of the media.

Information about the imager may also be inputted through user interface12. Imager information may include, for example, settings for the imageror scanner. Specific information about the scanner may include CTinformation, which may encompass such parameters as mAS(milliamp-seconds), slice thickness, speed, window, and level. Theimager or scanner information also might encompass MR (magneticresonance) imaging parameters such as time to echo, TR, NEX, FOV, slicethickness and spacing, voxel size, pulse sequence, flip angle, softwareversion, coils used, and time of acquisition. Other imaging informationsuch as ultrasound information or X-ray information may also be inputtedinto user interface 12.

Information about actuals (in contrast to information about equipmentsettings) may also be inputted through user interface 12 or developed inthe medical device 14. Actuals include, for example, the time sequenceof the procedure, the image, and the image quality of the region ofinterest (ROI). Actuals may also include information about hospital sitedata, which includes the location and size of the hospital together withthe number of like procedure performed at that hospital.

Information about the results of the selected procedure may also beinputted through user interface 12 (and/or directly sent to centraldatabase 16 from user U) or developed in the medical device 14.Result-oriented information may include final results such as patientoutcomes, image quality and satisfaction, quality of the study,diagnosis of the disease, diagnosis quality (e.g., the number ofmetastases found), user satisfaction with the equipment, informationabout complications, or even a final imaging report.

In addition, long-term information over multiple patients may beinputted through user interface 12 or developed in the medical device14. Long-term information includes, for example, the usage rate of theequipment, patterns of use for the equipment, the service history of theequipment, and the reliability history of the equipment.

The foregoing list of information that may be inputted through user U,user interface 12, or developed in the medical device 14 is meant to beillustrative of the type and variety of information that system 10 ofthe present invention may collect, tabulate, and store. However, it iscontemplated that other types of information also may be processed bythe present invention. Moreover, as would be understood by those skilledin the art, the type of information inputted by user U, inputted intouser interface 12, or developed in the medical device 14 depends uponthe particular procedure performed.

User input through user U or user interface 12 is not the only way inwhich system 10 of the present invention may acquire relevant data. Itis contemplated that information may be acquired by medical device 14 inan automated fashion when the information is available from a localdatabase or computer. For example, the age, weight, disease type, andmedical history of the patient may be acquired from the hospitalinformation system (HIS) in which the procedure is performed. In thiscase, user interface 12 may communicate with a computer or othersuitable equipment programmed to acquire information with minimal (orno) interaction by the practitioner or doctor who is performing theselected procedure.

User interface 12 communicates with medical device 14 to providerelevant information about a particular patient and procedure. Before,during and after the procedure is being performed, medical device 14generates procedure-specific information, which is also referred to asoperational information. The operational information may include aplethora of data about the procedure. The raw data information andoperational information are transmitted to central database 16 where theinformation is collated, tabulated, and stored. After analyzing thedata, central database 16 may select one or more related data entriesthat are relevant to the medical procedure based on certain parametersthat match or are closely related among the patient raw data andprocedural information inputted into central database 16.

Once selected, the one or more related data entries are relayed back tothe practitioner through medical device 14 and user interface 12.Alternatively, the related data entries may be communicated directly touser U from central database 16. The related entries preferably arerelayed to the practitioner before or during this or subsequent medicalprocedure to provide guidance to the practitioner for the medicalprocedure that is about to be performed or is being performed. Thepractitioner may be influenced by the information provided by therelevant data entries to modify the procedure.

A specific example in which system 10 of the present invention mayoperate is provided below.

It may be beneficial to connect an injector and an imager (or scanner)together so that they interface with one another to enhance the qualityand accuracy of a final diagnostic analysis. The injector providesinformation about the injection (volume, flow rate, patient specificdata, etc.) and relates it to a specific procedure performed (number ofslices, region of interest, visibility of lesions, diagnosis, etc.). Thescanner, in turn, interprets that data and performs a specific scancustomary to the selected procedure. Alternatively, the scanner may beprogrammed to suggest how to perform a particular scan based on theinformation provided by the injector.

In one embodiment, the injector may be programmed to sample periodicinformation about the injection volume, flow rates, and patient specificinformation and relate that information to the procedure performed. Forexample, the injector may sample the scanner information on regions ofthe body that are of interest to the physician, the number of slices (ofimage cross-sections) taken, and the results of the study. It may alsosample information about the outcome of the procedure, for example, thequality of the images taken, the visibility of the lesions, and thediagnosis reached by the physician.

The information collected is transmitted to a central computer ordatabase 16 where it is compared with other like parameters (such as thepatient's age, weight, health, and medical condition, etc.) foranalysis. After tabulating the information, central database 16 mayselect one or more similar analyses performed on other occasions (calledrelated entries) and relay that information to the practitioner so thatthe practitioner may use that information to the patient's benefitbefore or during the procedure.

If the procedure involves contrast media used for liver scans, forexample, the information collected may be compared with like proceduresperformed across the country or around the world. Once analyzed bycentral database 16, the collective information may be tabulated andreturned to the practitioner to help him (and the hospital) improveanalytical and therapeutic techniques. For example, for a givenprocedure, central database 16 may return related entries that suggest aparticular slice thickness, contrast volume, and/or injection rate toobtain the most accurate diagnostic result.

The same information also may help to save considerable amounts of moneywhen treating patients. As an example, it might be learned that aparticular liver scan requires on average 100 ml of contrast mediumrather than the traditionally used 150 ml. The availability of thisinformation might help a subsequent physician reduce the amount of mediathat is unnecessarily injected into the patient while, at the same time,reducing the cost of the procedure to the patient.

Reducing the quantity of contrast media injected into a patient also hasthe desired effect of increasing the safety of the diagnostic procedure.While contrast media are proven safe and effective, there is always thepossibility that a patient may have an adverse reaction to the contrastmedia selected. If the total quantity of contrast media used may bereduced, one direct effect is that the safety of the procedure isincreased because less media is injected into the patient to perform thediagnostic procedure.

Along the same lines, the same information may be used to establish newstandards for performing medical procedures. If it were learned that aparticular liver scan requires only 100 ml of contrast medium instead ofthe traditionally used 150 ml, 100 ml may be adopted as the new standardfor the medical procedure. This information could be made available tousers U through the system described herein, or it could be communicatedthrough journal articles, seminars, papers at conferences, or the othercommunications methods currently used to reach users U.

As technology improves and the quality of scanning improves, thatstandard may be altered over time. For example, after central database16 tabulates further procedures of the same type, it may be found thatonly 90 ml of contrast are needed (instead of the 100 ml establishedpreviously) and the standard may be altered again to reflect this. It ispossible, therefore, through the iterative operation of system 10, toprovide a constantly updated standard for medical procedures through thecollection, tabulation, and dissemination of information about medicalprocedures.

In addition, the same information may be used to suggest ways in whichmedical equipment may be improved. For example, it may be learnedthrough the collection and tabulation of information by system 10 of thepresent invention that there is a need for medical injectors to providecontrast media at a reduced flow rate, which may not be possible withexisting models. With this information in hand, manufacturers mayredesign the injectors that they produce to slow the injection rate,thereby providing more useful tools to practitioners that assist them inperforming their daily duties.

While the general structure and operation of the present invention hasbeen described in connection with the schematic illustrated in FIG. 1,there are several other embodiments of the present invention that areencompassed thereby.

For example, FIG. 2 illustrates a second embodiment of the presentinvention, system 20. Here, system 20 does not combine user interface12, medical device 14, and central database 16 in series. Instead, insystem 20, user interface 12, medical device 14 and central database 16are connected in a circular arrangement so that they communicate withone another in a slightly different manner. In system 20, user interface12 is connected by communication links 104, 106 to medical device 14 andvia communication links 118, 116 to central database 16.

As illustrated in FIG. 2, user U may communicate directly with userinterface 12 or central database 16 through appropriate communicationlinks 100, 102, 112, 114. While these two communication paths areillustrated, it should be noted that user U may also communicatedirectly with medical device 14. To simplify the figures, thisparticular communication path is omitted from the FIG. 2 of the presentinvention.

Connected in the manner shown in FIG. 2, system 20 may operate in thesame way as in the first embodiment illustrated in FIG. 1. Here, userinterface 12 may provide raw data information to medical device 14,which, in turn, communicates with central database 16 (via communicationlinks 108, 110) to retrieve related data entries. However, in thissecond embodiment, because user interface 12 is connected directly tocentral database 16 via communication links 116, 118, user U may accessrelated data directly from central database 16 through user interface 12without that information first being provided to medical device 14.Alternatively, user U may access and/or provide data to central database16 through communication links 112, 114.

FIG. 3 illustrates system 30, which is a first variation of the firstembodiment shown in FIG. 1. Here, a raw data source 22 is incommunication with user interface 12 via one or both of communicationlinks 120, 122. Raw data source 22 preferably is a database that storesinformation about a particular patient or procedure, among other typesof information. In one aspect, raw data source 22 may be a hospitalinformation system (HIS) in which patient-specific information and thepatient's medical history are stored. The user interface 12 can requestand receive information from the raw data source 22. Or, user U couldinteract with the raw data source 22 (via communication links 124, 126)and request that data be sent to the user interface 12 or directly touser U.

In one embodiment, it is intended that raw data source 22 be connectedto user interface 12 so that user interface 12 may access theinformation in raw data source 22 and provide that data to medicaldevice 14 and, ultimately, to central database 16. When raw data source22 is provided, user U need not input all of the relevant data about apatient or procedure through user interface 12 (or to central database16), because some of the information is provided by raw data source 22.

One anticipated benefit to the inclusion of raw data source 22 in system30 is the automated acquisition of raw data by system 30. When raw datais acquired in an automated fashion, it is anticipated that theoperation of the system of the present invention will be greatlyimproved, because interaction (through user interface 12, for example)by the practitioner may be greatly reduced. When the burden of inputtingdata through user interface 12 by the practitioner (user U) is reduced,it is anticipated that there will be a greater likelihood that pertinentraw data will be captured by system 30 than if the raw data were enteredby the practitioner manually. In addition, it is expected that the rawdata will be more reliable because the probability of user data entryerror will be reduced.

FIG. 4 illustrates a fourth embodiment of the present invention, system40, which is a second variation of the first embodiment illustrated inFIG. 1. Here, system 40 operates in the same manner as the embodimentspreviously described except that raw data source 22 is in communication(via communication links 128, 130) with medical device 14 rather thanuser interface 12. In addition, raw data source 22 is in communicationwith central database 16 via communication links 132, 134. In thisembodiment, raw data source 22 provides patient-specific information andprocedure information (among other types of information) directly tomedical device 14 or central database 16, leaving user interface 12 forinputting any remaining information not available from raw data source22. Alternatively, while not illustrated, communication links may beprovided from user U directly to central database 16. In all otherrespects, system 40 operates in the same manner as the embodimentspreviously described.

FIG. 5 illustrates a fifth embodiment, system 50, of the presentinvention, which is a first variation of the second embodimentillustrated in FIG. 2. In this embodiment, raw data source 22 isconnected to user interface 12 in the same manner as with system 30illustrated in FIG. 3. In system 50, user interface 12 is connected tocentral database 16 and medical device 14 in the same manner as withsystem 20. Raw data source 22 operates in the same manner as previouslydescribed, as does the remainder of system 50. In addition, user U is incommunication with raw data source 22 via communication links 124, 126.

FIG. 6 illustrates a sixth embodiment, system 60, of the presentinvention. System 60 is a second variation of the second embodiment ofthe present invention illustrated in FIG. 2. System 60 differs fromsystem 20 in that raw data source 22 is connected to medical device 14(via communication links 128, 130) to input raw data into medical device14. Moreover, user U is connected to raw data source 22 viacommunication links 124, 126 and also to user interface 12, aspreviously described. In all other respects, system 60 operates like thesystems previously described.

FIG. 7 illustrates a seventh embodiment, system 70, of the presentinvention. System 70 is a third variation of system 20 shown in FIG. 2.In system 70, more than one user interface 12, 12′ and more than onemedical device 14, 14′ are shown connected to central database 16 viacommunication links 108, 110 and 136, 138, respectively. As discussedabove, the present invention contemplates that many medical devices 14,14′ and associated input or user interface devices 12, 12′ will beconnected to the same central database 16 so that practitioners fromaround the world may share data with one another. In all other respects,system 70 operates like the previously described systems. Medicaldevice(s) #1 14 and medical device(s) #2 14′ may be different, similar,or identical devices with great or minimal physical distance betweenthem.

FIG. 8 illustrates an eighth embodiment, system 80, of the presentinvention. System 80 presents a third variation of system 10 illustratedin FIG. 1. In system 80, several user interfaces 12, 12′ and medicaldevices 14, 14′ are connected to central database 16 so thatpractitioners from around the world may share information with oneanother as in system 70. Here, user interface 12′ is connected tomedical devices #2 14′ via communication links 144, 146. In all otherrespects, system 80 operates in the same manner as the systemspreviously described.

While not illustrated, in both system 70 and system 80, user U may beconnected, via communication links to one or more of user interfaces 12,12′, medical devices 14, 14′, a central database 16. In addition, one ormore raw data sources 22 may also be connected to the systems 70, 80 asdescribed previously.

FIG. 9 provides a schematic illustration of a system 90 according to oneaspect of the present invention. Here, a number of medical devices,which are divided into imagers 24 and injectors 26, are shown in usewith several patients. Imagers 24 may be of different types, forinstance, MRI scanners, CT scanners, and ultrasound scanners. Differentpatients may have one or more imaging procedures with differentequipment or the same equipment at different times. Different patientsmay undergo similar or different treatments 28 based upon the diagnosismade in part with the results of the imaging studies. All of theinformation for the various patients from the various studies andtreatments 28 is preferably entered into a central database 16 using oneof the systems described herein. The choice of imaging procedure andtreatment for a specific patient can likewise be influenced byinformation available from the central database 16 through one of thesystems described herein. The present invention is not limited solely touse by practitioners who wish to improve the medical techniques andstandards that they employ. As FIG. 10 illustrates, any number of usersU may access central database 16 to derive information relevant to thatparticular user's U operation. The present invention contemplates thatdata may be collected from any number of sources and may be accessed byany number of users U interested in that information.

For example, one user U that may rely on system 10 of the presentinvention may be a marketing or research firm charged withresponsibility for developing new products or improving existingproducts. In such an instance, the marketing or research firm mightincorporate software into user interface 12 or medical device 14 thatcollects information about the manner in which a particular medicaldevice is used or the general reputation of the product in theparticular field.

In this example, in the case of an injector 26 that has a number offunctions incorporated into the memory, the software may be designed tocollect information on the frequency with which practitioners rely on aparticular function. If, after collecting information concerning a largenumber of procedures, it is determined that the function is not usedwith any frequency, the marketing or research firm might suggest thatthe function be removed from injector 26 to reduce its overall cost tothe consumer.

Alternatively, a marketing or research firm might incorporate into thesoftware for particular medical device 14 questions directed to thepractitioner that prompt responses about the practitioner's satisfactionwith the device. Also, the software might prompt responses designed toprovide input that might assist in developing future devices. Forexample, the software present in either medical device 14 or in userinterface 12 may ask the practitioner if injector 26 operates at anacceptable speed. Depending upon the statistical results of the query,as tabulated by central database 16, the marketing or research firmmight recommend that injector 26 be modified to address thepractitioners' concerns by increasing or decreasing the injection speedof injector 26.

It is also contemplated that government and regulatory agencies might bepotential users U of the present invention. If so, government andregulatory agencies might work with the manufacturers to incorporateroutines in the software of medical device 14 or user interface 12 todetermine the frequency and efficacy of a particular medical procedurefor purposes of establishing guidelines with respect to thoseprocedures.

Alternatively, through information available through the centraldatabase 16, Medicare could determine that a particular medicaldiagnostic was particularly well suited to evaluating the overall healthof a patient, and might add the procedure to the list of procedures thatMedicare would pay for as part of its coverage.

Similarly, if the FDA were user U of the system 10 (or any othervariation of system 10) of the present invention, the FDA coulddetermine the efficacy of certain pharmaceutical compounds. To acquirethis information, software might be incorporated into user interface 12or medical device 14 to monitor patient blood levels and obtaininformation about the results of the use of those pharmaceuticalcompounds. With results tabulated over a large cross-section of theusing public, the FDA could compare one compound to another to makedecisions about various pharmaceuticals that are within its regulatorycontrol.

In such an instance, the FDA might monitor statistically the occurrenceof side effects for a particular compound. If the side effects of aparticular drug were found to exceed acceptable limits, the FDA mightrely on the data acquired to initiate an investigation of the compoundor to prevent further distribution of the pharmaceutical until thesafety of the drug has been fully reevaluated.

Professional societies are also contemplated as potential users ofsystem 10 of the present invention. As organizations made up of users U,professional societies may work with the manufacturers to incorporateinto the software of system 10 particular queries or data collectionfunctions that assess the types and frequencies of procedures performedby individual members of the organization. The information collectedcould then be used by the professional society to determine if there areany areas in the profession or professional development that need to beaddressed.

Researchers may also be a group of users U that may rely on theoperation of system 10 (or any variation of system 10) to collectresearch information for a particular study. Using the system 10, aresearcher may collect data pertinent to a particular inquiry over alarge number of users U, especially if there are a large number ofpractitioners who are contributing data to central database 16. If so, aresearcher might be able to acquire a significant amount of statisticaldata about a particular procedure, product, or standard that could beobtained today only through the expenditure of an enormous amount ofmoney.

Other users U also may benefit from the operation and use of system 10(or systems 20, 30, 40, 50, 60, 70, 80, and 90). For example, healthinsurers might collect information regarding a particular diagnosticprocedure for purposes of determining the appropriate cost of aparticular procedure. In this example, health insurers might work withthe manufacturers to include in the software in user interface 12 ormedical device 14 the ability to collect the costs charged for orrelated to a particular procedure. If so, health insurers could thencompare the costs charged by particular hospitals for a particularprocedure with the goal of reducing the overall cost of health care toconsumers.

Hospital Consortiums, HIS vendors, injector vendors (and themanufacturers of medical device 14), imager vendors, third partyvendors, and third party servicers also may be among users U of thesystem of the present invention. Regardless of the particular user U andthe ultimate goals of that user U, in each case, user U may work withthe manufacturers to incorporate into the software of system 10 routinesand queries that collect a wide variety of information about particularprocedures, equipment, and standards used. In this way, medicaltechniques, equipment, and standards may be continually updated, in aniterative fashion, as the statistical information accumulates in centraldatabase 16.

As mentioned above, the various embodiments of the system of the presentinvention are designed to provide an iterative analytical function thatmay be applied to improve medical techniques, equipment and standards.As information is collected, trends in the information can be analyzedso that best practices may be established in the medical profession, sothat equipment may be updated to accommodate practitioner demands, andso that standards may be developed or refined. The various embodimentsof the system of the present invention, therefore, provide an apparatusand method that collects, tabulates, and stores information that can beaccessed in a selective manner to disseminate information topractitioners with the ultimate goal of improving the quality of healthcare.

While the word “central” in central database 16 might imply to thereader a central physical location, with current rapid improvements ininformation technology, this is no longer an implementation requirement.It is possible to have a database that is distributed among manycomputers at one site, at various sites around the country, or evenaround the world. It is also possible for the data to reside on variousmedical devices 14. In this case, an inquiry may poll the variousmedical devices 14 to get the information only when it is needed for aresponse. Or an inquiry could “launch” a request, and the request couldtravel from medical device 14 to medical device 14, gathering thenecessary information along the way. The essential function of thecentral database 16 is to provide a way to collect the appropriate datain response to an inquiry. As new information technologies aredeveloped, they can be used to perform this central database function.For example, users U may be able access central database 16 via aninternet interface to create inquiries.

There are also other methods for medical practitioners to receive and beinfluenced by the information and analyses derived from this inventionin addition to the user interface 12. The results of an inquiry can bepublished in an electronic or paper format by a manufacturer, aprofessional organization, or the FDA. Or, they can be incorporated intostandards, reimbursement policies, or practice guidelines that aresubsequently published in some form. Or medical practitioners may accessthem through the Internet. The information also can be incorporated intoin-service training conducted by the medical device manufacturer(s) orseller(s).

In all of the above system descriptions, direct communication paths areshown between specific system elements. Given the communicationsinfrastructure of today and the possibilities of future developments,the specific communication path may be circuitous or indirect. Theoperation of the present invention results in information beingtransmitted from one place to the other in a reliable and timely manner.The details of the path route or technology used are inconsequential.The benefits of this invention for information communication and use arenot limited by the specifics of physical connectedness. For instance,communications path 114 in FIG. 1 can be a paper article or writtenprocedure recommendation in situations where such a response issufficient. As a second example, medical device 14 may communicate withcentral database 16 through user interface 12. The fact that medicaldevice 14 communicates with central database 16 though a third device ordevices, either shown or not shown, is within the scope of thisinvention. Thus the various communications paths show in FIG. 1 through8 are some from among many possibilities.

Also, all the communication paths are preferably, but not necessarily,two-way. When user U interacts with user interface 12, there is normallya two-way communication, because user U prefers feedback to know thatwhat was provided was the input that was desired (that user U pressedthe right key, for instance). Normally, the communications between twodevices involves at least the two-way communications embodied in theRS-232 protocol. More commonly, there is some type of acknowledgementmessage sent to confirm satisfactory transmission of the informationfrom one device to another. However, there are examples, such as theremote reading of water meters where the communication in one directionis as simple as a signal to indicate “send your data,” and there is noacknowledgement that the data is subsequently received.

FIG. 11 contains plots of data collected to support an analyticalexample to illustrate the usefulness and power of the system describedherein to improve medical practice and the design of medical products.The plots are of hypothetical data that have been collected in centraldatabase 16 from many similar medical procedures over time.

FIG. 11A shows a histogram of contrast injection volumes for a CT studylooking for cancer metastases to the liver. Almost all procedures areperformed with doses between 100 and 150 ml. The volume of the injectionis a piece of data that the user selects through user interface 12. Thisdata is then sent to medical device 14, in this case the injector. Fromthere it goes to central database 16.

Through a second medical device 14, the CT image is taken and ifmetastases are seen, they can be indicated on the image by the user andtheir image contrast level is compared to that of the normal livertissue. In CT imaging, the image contrast is measured in Hounsfieldunits. To simplify the display of the data, the contrast is grouped into4 classes, 1, 2, 3, and 4.This image contrast of the metastases is thencommunicated to central database 16.

FIG. 11B is a bubble chart showing the relationship between imagecontrast and volume of contrast injected for a number of studies. Thesize of the bubble shows the relative occurrence of that image contrastlevel given an injection of a specified volume of contrast media. Whilegreater volumes may be said to give slightly more image contrast, thereis really no quantifiable relationship between the two. The few very lowvolume injections produce image contrast in the 3 and 4 range and a fewinjections with volume in the highest range produced image contrast atlevel 2.

Information about the patients' weights can increase the benefit of theanalysis. The patient's weight information can be entered by user Uthrough user interface 12 or can be retrieved from raw data source 22.It is then sent to the central database 16. FIG. 11C shows thedistribution of procedures with the various volumes of contrast perkilogram weight of the patient. As shown, the curve is approximatelynormal with a slight skewing to the high side. When the bubble chart isreplotted with image contrast as a function of volume contrast perkilogram as in FIG. 11D, there is a clear relationship between the two,although there are still other factors that affect the relationship.Regression analysis could be applied to determine the strength of thisrelationship and to test the strengths of the effect of other factors,for instance imaging equipment type or settings, or patient circulatorysystem health or state of compromise.

By asking user U, after the procedure, to rate the confidence of theirdiagnosis after the procedure through user interface 12, it is possibleto learn more and further improve the medical procedure. The user'sassessment of their confidence in the diagnosis is sent to centraldatabase 16. FIG. 11E shows the relationship between diagnosisconfidence on a 4-point scale and image contrast, also on a 4-pointscale. In almost all cases, and image contrast of 3 or 4 gives adiagnosis confidence of 3 or 4.

This information can be used in conjunction with FIG. 11D to develop apractice recommendation. In this example, the recommendation would bethat there is no need for any contrast doses above level E because thisvolume per kilogram yields image quality sufficient for a high diagnosisconfidence. Also, the recommendation would be that doses at or belowlevel C should be avoided. There is some option among levels D and E.Level E guarantees, aside from human error, a sufficient image contrastto make a confident diagnosis. Level D has a small chance of producing adiagnosis confidence level of 2 or 1. If the other significant factorscould be determined and controlled, then contrast level D could berecommended. There is considerable cost savings improvement available byavoiding giving more contrast than needed—levels F and G. And, byavoiding levels A through C, the chance of misdiagnosis or having torepeat the study can be significantly reduced, also improving thequality of health care and reducing costs.

As mentioned earlier, this information and analysis can also be veryuseful to manufacturers as they design improved products. In this case,the recognition that volume per kilogram is the most important factor indetermining image contrast and, thus, diagnosis confidence couldindicate that a fluid injector system needs to be designed to allow muchmore flexible dosing that is currently available with prefilled syringesof a single size and contrast bottle which are available primarily in 25ml increments.

Related data is the term applied to data derived from the original dataplaced into central database 16. Related data is preferably stored incentral database 16 for ease of access, but in the spirit of distributeddatabases, it may be stored elsewhere or derived as needed. In theexample related through FIG. 11, related data is the histogram ofoccurrence of the various volumes per kilogram, and the 3 bubble plotsof 11B, 11D, and 11E.

While the invention has been described by way of exemplary embodiments,it is understood that the words which have been used herein are words ofdescription, rather than words of limitation. For example, medicalstandards are not limited to formally approved standards. It includesbest practices or simply standard or common practices of anorganization, a particular imaging suite, or an individual. Also, thedesignations before, during and after are meant to indicate expected orcommon practice. A user can enter all the information after use,although they cannot enter all the information before use, since theresults of the procedure cannot be known until the procedure isperformed. Changes may be made, within the purview of the appendedclaims without departing from the scope and the spirit of the inventionin its broader aspects.

1-3. (canceled)
 4. A system for collection, management and disseminationof information relating to medical procedures, the system comprising:(a) a plurality of interface devices, each of the interface deviceshaving a local database and being adapted to communicate with at leastone of an injector, a scanner and at least one other device, each of theinterface devices being further adapted (I) to receive raw data suchthat the raw data includes at least one of fluid administrationinformation from the injector, imaging study information from thescanner and patient identification information and (II) to matchautomatically, for each of the medical procedures, the fluidadministration information and the imaging study information based onthe patient identification information and to store the result thereofin the local database as a raw data entry; and (b) a central databasefor operation on at least one computer and being enabled therethrough tocommunicate with each of the interface devices and to collect, tabulateand store therein the raw data entries received from the local databasesof the interface devices; wherein the central database is furtheradapted to select at least one related entry derived from the raw dataentries stored thereon and to enable the at least one related entry tobe disseminated to at least one of the interface devices.
 5. The systemof claim 4 wherein the at least one related entry may take the form ofat least one of the raw data entries.
 6. The system of claim 4 whereinthe at least one related entry may take the form of a set of parametersassociated with at least one of an injection procedure and an imagingprocedure.
 7. The system of claim 4 further comprising a user interfacein communication with the at least one computer, the user interfacebeing adapted to enable entry into the central database of at least oneof an injection procedure and an imaging procedure, with the centraldatabase enabling the at least one of the injection procedure and theimaging procedure to be disseminated to at least one of the interfacedevices.
 8. The system of claim 4 wherein the raw data further includesinformation about at least one of the injector, the scanner, the atleast one other device, actuals, a result of an injection procedure, aresult of an imaging procedure, equipment used, and long terminformation inclusive of usage rate, patterns of use, service historyand reliability history of at least one of the injector, the scanner andthe at least one other device.
 9. The system of claim 8 wherein theinformation about the equipment used includes at least one of a size ofsyringe(s) used, a volume of syringe(s) used, a type of fluid(s) used, amanufacturing lot of fluid(s) used, a rate(s) of flow of fluid(s) used,a volume of fluid(s) used, a type of catheter(s) used, and, generally, anumber of disposables used.
 10. The system of claim 4 wherein at leastsome of the interface devices are integrated with a medical device, 11.The system of claim 10 wherein the medical device is one of theinjector, the scanner, a heart monitor and a respirator.
 12. The systemof claim 4 wherein the central database is in communication with a rawdata source, the raw data source comprising at least one of a hospitalinformation system (HIS), a radiology information system (RIS), anintranet, the Internet, a picture archiving and communication system(PACS) and an other external information system.
 13. The system of claim12 wherein at least one of the interface devices is in communicationwith the raw data source.
 14. The system of claim 4 wherein the at leastone computer is a plurality of computers, and the central database isone of (i) distributed among the plurality of computers at one site and(ii) distributed among the plurality of computers at various sites. 15.The system of claim 4 wherein the at least one related entry comprisesguidance based on the raw data entries and a medical standard employedtherewith.
 16. The system of claim 7 wherein the user interface isfurther adapted to enable entry of information affecting operation ofthe at least one interface device into the at least one computer fordissemination thereby to the at least one interface device for usethereby.
 17. The system of claim 4 wherein the imaging study informationincludes x-ray information.
 18. A system for collection, management anddissemination of information relating to medical procedures, the systemcomprising: (a) a central database for operating on a computer and beingenabled therethrough to communicate with each of a plurality ofinterface devices, each of the interface devices having a local databaseand being adapted to communicate with at least one of an injector, ascanner and at least one other device, each of the interface devicesbeing further adapted (I) to receive raw data such that the raw dataincludes at least one of fluid administration information from theinjector, imaging study information from the scanner and patientidentification information, and (II) to relate, for each of the medicalprocedures, the fluid administration information and the imaging studyinformation based on the patient identification information and to storethe result thereof in the local database as a raw data entry; and (b)the central database via the computer being adapted (I) to collect,tabulate and store therein the raw data entries received from the localdatabases of the interface devices and (II) to select at least onerelated entry derived from the raw data entries stored thereon and toenable the at least one related entry to be disseminated to at least oneof the interface devices.
 19. The system of claim 18 wherein the atleast one related entry may take the form of at least one of the rawdata entries.
 20. The system of claim 18 wherein the at least onerelated entry may take the form of a set of parameters associated withat least one of an injection procedure and an imaging procedure.
 21. Thesystem of claim 18 wherein the computer includes a user interface incommunication therewith, the central database permitting entry via theuser interface of at least one of an injection procedure and an imagingprocedure, with the central database enabling the at least one of theinjection procedure and the imaging procedure to be disseminated to atleast one of the interface devices.
 22. The system of claim 18 whereinthe raw data further includes information about at least one of theinjector, the scanner, the at least one other device, actuals, a resultof an injection procedure, a result of an imaging procedure, equipmentused, and long term information inclusive of usage rate, patterns ofuse, service history and reliability history of at least one of theinjector, the scanner and the at least one other device.
 23. The systemof claim 21 wherein the information about the equipment used includes atleast one of a size of syringe(s) used, a volume of syringe(s) used, atype of fluid(s) used, a manufacturing lot of fluid(s) used, a rate(s)of flow of fluid(s) used, a volume of fluid(s) used, a type ofcatheter(s) used, and, generally, a number of disposables used.
 24. Thesystem of claim 18 wherein at least some of the interface devices areintegrated with a medical device.
 25. The system of claim 24 wherein themedical device is one of the injector, the scanner, a heart monitor anda respirator.
 26. The system of claim 18 wherein the central database isin communication with a raw data source, the raw data source comprisingat least one of a hospital information system (HIS), a radiologyinformation system (RIS), an intranet, the Internet, a picture archivingand communication system (PACS) and an other external informationsystem.
 27. The system of claim 26 wherein at least one of the interfacedevices is in communication with the raw data source.
 28. The system ofclaim 18 wherein the computer is a plurality of computers, and thecentral database is one of (i) distributed among the plurality ofcomputers at one site and (ii) distributed among the plurality ofcomputers at various sites.
 29. The system of claim 18 wherein the atleast one related entry comprises guidance based on the raw data entriesand a medical standard employed therewith.
 30. The system of claim 21wherein the user interface is further adapted to enable entry ofinformation affecting operation of the at least one interface deviceinto the computer for dissemination thereby to the at least oneinterface device for use thereby.
 31. The system of claim 18 wherein theimaging study information includes x-ray information.
 32. Acomputer-readable medium comprising an executable program storedthereon, the executable program configured to cause a computer to createa central database for use in collection, management and disseminationof information relating to medical procedures, the central database inoperation on the computer to perform the following steps: (a)communicating with each of a plurality of interface devices, each of theinterface devices having a local database and being adapted tocommunicate with at least one of an injector, a scanner and at least oneother device, each of the interface devices being further adapted (I) toreceive raw data such that the raw data includes at least one of fluidadministration information from the injector, imaging study informationfrom the scanner and patient identification information, and (II) torelate, for each of the medical procedures, the fluid administrationinformation and the imaging study information based on the patientidentification information and to store the result thereof in the localdatabase as a raw data entry; and (b) collecting, tabulating and storingon the central database the raw data entries received from the localdatabases of the interface devices; (c) selecting at least one relatedentry derived from the raw data entries stored on the central database;and (d) enabling the at least one related entry to be disseminated fromthe central database to at least one of the interface devices.
 33. Thecomputer-readable medium of claim 32 wherein the at least one relatedentry may take the form of at least one of the raw data entries.
 34. Thecomputer-readable medium of claim 32 wherein the at least one relatedentry may take the form of a set of parameters associated with at leastone of an injection procedure and an imaging procedure.
 35. Thecomputer-readable medium of claim 32 wherein the computer includes auser interface in communication therewith, the central databasepermitting entry via the user interface of at least one of an injectionprocedure and an imaging procedure, with the central database enablingthe at least one of the injection procedure and the imaging procedure tobe disseminated to at least one of the interface devices.
 36. Thecomputer-readable medium of claim 35 wherein the user interface isadapted to enable entry of information affecting operation of the atleast one interface device into the computer, the computer forpermitting dissemination of the operation-affecting information to theat least one interface device for use thereby.
 37. The computer-readablemedium of claim 32 wherein the raw data further includes informationabout at least one of the injector, the scanner, the at least one otherdevice, actuals, a result of an injection procedure, a result of animaging procedure, equipment used, and long term information inclusiveof usage rate, patterns of use, service history and reliability historyof at least one f the injector, the scanner and the at least one otherdevice.
 38. The computer-readable medium of claim 37 wherein theinformation about the equipment used includes at least one of a size ofsyringe(s) used, a volume of syringe(s) used, a type of fluid(s) used, amanufacturing lot of fluid(s) used, a rate(s) of flow of fluid(s) used,a volume of fluid(s) used, a type of catheter(s) used, and, generally, anumber of disposables used.
 39. The computer-readable medium of claim 32wherein the central database further communicates with a raw datasource, the raw data source comprising at least one of a hospitalinformation system (HIS), a radiology information system (RIS), anintranet, the Internet, a picture archiving and communication system(PACS) and an other external information system.
 40. Thecomputer-readable medium of claim 32 wherein the computer is a pluralityof computers, and the central database is one of (i) distributed amongthe plurality of computers at one site and (ii) distributed among theplurality of computers at various sites.
 41. The computer-readablemedium of claim 32 wherein the at least one related entry comprisesguidance based on the raw data entries and a medical standard employedtherewith.
 42. The computer-readable medium of claim 32 wherein theimaging study information includes x-ray information.